A Phase II/III, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Prurigo nodularis Patients with moderate to severe pruritus

JRCT ID: jRCT2011200017

Registered date:24/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prurigo nodularis with pruritus who are inadequately controlled by existing therapies
• Date of first enrollment: 07/12/2020
• Target sample size: 210
• Study type: Interventional
• Intervention(s): subcutaneous administration of nemolizumab

Outcome(s)

• Primary Outcome: Parcent change from baseline of weekly average in Peak pruritus-Numeric rate scale (PP-NRS) at Week16
• Secondary Outcome: Proportion of subjects achieving IGA 0 or 1 at Week 16

Key inclusion & exclusion criteria

• Age minimum: >= 13age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Prurigo nodularis with moderate or severe pruritus

Exclude criteria

-Patients with immune deficiency
-Patients with body weight less than 30.0kg
-Patients with Hepatitis B virus or hepatitis C virus infection
-Patients with Evidence of tuberculosis (TB) infection
-Pregnant or lactating women.

Related Information

• Primary Sponsor: Nishiura Tomoyuki